Antibacterial Sutures: Guidelines and Procurement Considerations

July 24, 2023
20 minutes read

Antibacterial Sutures: Guidelines and Procurement Considerations

Updated August 2026 | Originally published July 24, 2023

Antibacterial sutures are one component within a broader surgical site infection (SSI) prevention program. Current guidance does not treat every antimicrobial or antiseptic suture as interchangeable, nor does it establish antimicrobial-coated sutures as a replacement for established infection-prevention practices.

The strongest recent recommendation comes from the 2025 Surgical Infection Society (SIS) guideline. It recommends triclosan-coated suture for incision closure after abdominal operations in adults to reduce SSI risk, assigning the recommendation Grade 1A (strong recommendation, high-quality evidence). The authors describe the benefit as small but significant and emphasize the specific clinical context.

Other major guidelines use differently weighted recommendations:

  • 2022 SHEA/IDSA/APIC update: Places antiseptic-impregnated sutures among “Additional Approaches” to SSI prevention, with moderate-quality evidence
  • CDC 2017 SSI guideline: States that triclosan-coated sutures may be considered for SSI prevention (Category II recommendation: weak, moderate-quality evidence)
  • WHO guidelines: Provides a conditional recommendation for triclosan-coated sutures based on moderate-quality evidence

These distinctions matter. Evidence supporting one coating, suture material, procedure type, or clinical setting should not automatically apply to every product marketed as antibacterial or antimicrobial.

This guide reviews current evidence frameworks, FDA regulatory considerations, product-selection factors, and procurement practices for antibacterial and antiseptic-coated surgical sutures. It is intended for licensed healthcare professionals and procurement teams. Clinical product selection should follow the product’s current labeling, Instructions for Use (IFU), applicable guidelines, and institutional protocols.

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Why Suture Selection Requires Clinical Context First

Suture procurement is not simply a choice between coated and uncoated products.

A surgical suture must first meet the clinical requirements of the tissue, closure technique, expected healing period, and procedure. Essential factors include absorbability, material composition, filament structure, tensile strength, needle configuration, size, handling characteristics, and anatomical use.

An antimicrobial coating represents an additional product characteristic. It should not override the underlying clinical requirements for the suture itself.

Terminology adds complexity. Terms such as antibacterial suture, antimicrobial-coated suture, antiseptic-impregnated suture, and triclosan-coated suture appear across manufacturers, clinical literature, and guidelines—but not always in the same way.

For procurement and compliance purposes, the specific product technology matters.

The 2025 SIS recommendation addresses triclosan-coated sutures for abdominal surgery incision closure. WHO’s supporting evidence review focused on triclosan-coated absorbable sutures. SHEA/IDSA/APIC uses the broader term antiseptic-impregnated sutures. Evidence supporting one category should not automatically extend to every product carrying an antimicrobial or antibacterial label.

The appropriate comparison is not:

antibacterial suture versus ordinary suture

but rather:

a specific antimicrobial-coated suture configuration versus an appropriate alternative that meets the same closure requirements

Healthcare professionals should review the specific manufacturer’s current labeling and IFU to determine indications, contraindications, warnings, tissue applications, and technical characteristics.

Understanding SSI Prevention Strategy

SSIs are infections associated with surgical procedures. They are a major focus for hospital and ambulatory surgical infection-prevention programs.

Current SSI prevention uses multiple complementary measures rather than relying on a single product or intervention.

The SHEA/IDSA/APIC framework distinguishes two categories:

  • Essential Practices: Core measures acute-care hospitals should implement broadly
  • Additional Approaches: Measures organizations may consider after implementing Essential Practices and identifying additional improvement opportunities through surveillance or risk assessment

Antiseptic-impregnated sutures fall into the second category.

This classification is important for procurement decisions. An antimicrobial-coated suture should not be positioned as a stand-alone infection-control solution. Instead, product evaluation should occur within the organization’s broader SSI-prevention framework, which may include preoperative, intraoperative, postoperative, environmental, procedural, and surveillance practices.

The role of the suture is adjunctive.

Individual clinical outcomes vary. Using an antimicrobial-coated suture does not eliminate SSI risk. Guideline recommendations describe population-level evidence, not individual-patient guarantees.

The 2025 Surgical Infection Society Guideline

What the SIS Recommends

The 2025 SIS guideline addresses a specific clinical question: do triclosan-coated sutures, compared with non-triclosan-coated sutures, reduce postoperative SSI risk in adult patients undergoing abdominal surgery?

After reviewing randomized controlled trials and meta-analyses, SIS recommends triclosan-coated suture for incision closure following abdominal operations to reduce SSI risk. The recommendation is Grade 1A (strong recommendation, high-quality evidence).

SIS describes the evidence as showing a small but significant benefit in abdominal surgery and notes variation among the studies and clinical environments in the evidence base.

What Grade 1A Means (And Does Not Mean)

Grade 1A indicates a strong recommendation within the specific clinical context studied.

It does not mean triclosan-coated sutures are recommended for every operation, every wound classification, every anatomical site, or every patient population.

The SIS clinical question defined the scope: adult abdominal surgery.

Procurement teams should avoid converting this into a generalized claim such as “antibacterial sutures are recommended for all surgeries.”

More accurate: SIS recommends triclosan-coated sutures for incision closure after abdominal operations in adults, based on high-quality evidence evaluated for that clinical context.

When evaluating coated sutures for a different specialty or surgical site, the clinical team should examine evidence and recommendations relevant to that specific application.

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SHEA/IDSA/APIC 2022 Update

The Strategies to Prevent Surgical Site Infections in Acute-Care Hospitals: 2022 Update uses a different framework.

It classifies antiseptic-impregnated sutures as an Additional Approach to SSI prevention and assigns moderate quality of evidence. This represents a reclassification from the prior guidance.

“Additional Approach” has a defined meaning: these interventions may be considered when essential practices are implemented and local data suggests additional improvement opportunities remain.

This makes local clinical governance important.

A hospital or surgical facility considering antiseptic-impregnated sutures should evaluate:

  • Current SSI surveillance data
  • Procedure mix and patient population
  • Existing infection-prevention measures
  • Applicable specialty guidance
  • Product labeling and IFU
  • Clinician experience and workflow
  • Product availability and standardization requirements

Procurement can support that process, but clinical justification should come from appropriate surgical, infection-prevention, or healthcare leadership.

CDC and WHO Guidance

CDC 2017 SSI Guideline:

CDC states that clinicians should consider the use of triclosan-coated sutures for the prevention of SSI. The recommendation is Category II (weak recommendation, moderate-quality evidence with potential trade-offs between benefits and harms).

This recommendation is supportive but less directive than the procedure-specific SIS Grade 1A.

WHO Global Guidelines:

WHO suggests using triclosan-coated sutures for reducing SSI risk independent of surgery type. This is a conditional recommendation supported by moderate-quality evidence.

A critical detail: WHO’s evidence review evaluated triclosan-coated absorbable sutures. WHO noted that it did not identify comparable evidence evaluating other antimicrobial agents.

This has direct implications for procurement language. Evidence supporting triclosan-coated sutures should not automatically extend to iodine-containing, silver-containing, or other antimicrobial-labeled products without product-specific evidence and appropriate regulatory labeling.

Triclosan-Coated Sutures: What the Evidence Covers

Triclosan is an antiseptic agent incorporated into surgical suture coatings. Triclosan-coated suture is the technology most directly addressed by SIS, CDC, and WHO recommendations.

Depending on the particular product, triclosan coating may be used with different underlying absorbable suture materials and constructions. The clinical characteristics of the underlying suture—including strength retention, absorption profile, handling, tissue indication, and filament structure—remain relevant.

Therefore, the appropriate comparison is:

a specific antimicrobial-coated suture configuration versus an appropriate alternative that meets the same closure requirements

not:

antibacterial suture versus ordinary suture

Healthcare professionals should use the specific manufacturer’s current labeling and IFU to determine indications, contraindications, warnings, precautions, tissue applications, and technical characteristics.

Other Antimicrobial or Antiseptic Suture Technologies

Products using antimicrobial technologies other than triclosan should be evaluated independently.

A broad category label does not establish clinical equivalence.

Guideline evidence can differ based on:

  • Antimicrobial agent
  • Concentration or coating technology
  • Suture substrate
  • Absorbability
  • Filament construction
  • Surgical procedure and tissue type
  • Closure layer
  • Patient population
  • Study design and comparator

Avoid assuming that a guideline mentioning “antiseptic-impregnated sutures” supports every antimicrobial product commercially available.

When evaluating a different antimicrobial technology, review the specific product’s FDA regulatory information, manufacturer labeling and IFU, and clinical evidence applicable to the proposed use.

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FDA Regulatory Framework for Surgical Sutures

Surgical sutures are medical devices. Most commonly used surgical suture categories are regulated by FDA as Class II devices subject to the 510(k) premarket-notification pathway.

FDA’s surgical suture special-controls guidance covers absorbable polydioxanone, absorbable poly(glycolide/L-lactide), gut, polypropylene, polyamide, silk, stainless steel, expanded polytetrafluoroethylene, and other designated categories.

This distinction is important for compliant content. Medical device terminology should not automatically borrow prescription-drug language. Depending on the device and regulatory pathway, FDA-cleared may be appropriate where “FDA-approved” is not.

For any individual suture product, healthcare organizations should verify its specific regulatory status rather than applying a generic FDA claim.

FDA Expectations for Suture Labeling

FDA’s special-controls guidance states that surgical suture device descriptions should identify relevant materials, including coatings and additives, along with suture size and other product characteristics.

FDA expects suture labeling to address:

  • Absorbability or nonabsorbability
  • Material composition
  • Packing fluids, dyes, or coatings
  • Intended surgical uses and anatomical sites
  • Relevant patient populations where applicable
  • Absorption characteristics for absorbable sutures
  • Tensile-strength characteristics
  • Contraindications and warnings
  • Single-use labeling

These product-specific characteristics must remain central to procurement review. An antimicrobial designation alone is not enough to establish clinical suitability.

How to Evaluate Antibacterial Sutures for Procurement

Step 1: Start With the Clinical Requirement

The first question should be what type of suture the clinical team requires.

Relevant characteristics:

  • Absorbable or nonabsorbable material
  • Monofilament or braided construction
  • USP size
  • Suture length
  • Needle type and curvature
  • Needle dimensions
  • Tensile-strength retention profile
  • Absorption profile
  • Tissue indication (skin, fascia, muscle, etc.)
  • Closure layer
  • Sterility and packaging configuration
  • Antimicrobial coating (when clinically selected)

This sequence helps prevent a coating feature from becoming the primary selection criterion when other characteristics are more fundamental to safe and appropriate closure.

Step 2: Confirm the Exact Product Configuration

Closely related suture products can have different needle configurations, lengths, sizes, materials, coatings, and intended applications.

Procurement records should use an exact catalog number, item number, UDI where available, or another sufficiently specific identifier.

Descriptions such as “antibacterial suture” or even “triclosan suture” may be too broad for reliable ordering.

Exact-item controls also reduce substitution risk. If a requested product becomes unavailable, an alternative should not be assumed clinically interchangeable because it appears in the same general product category. Any clinically meaningful substitution should follow the healthcare organization’s approval process.

Step 3: Review Current Labeling and IFU

Before adding a product to a formulary or purchasing standard, confirm the current manufacturer documentation.

The review should address:

  • Indications for use
  • Material composition
  • Antimicrobial coating or additive
  • Contraindications and warnings
  • Suture absorption or strength-retention profile
  • Needle characteristics
  • Sterility requirements
  • Single-use requirements
  • Storage requirements
  • Packaging integrity requirements

For applicable products, procurement teams can also confirm that the product and configuration correspond to the appropriate FDA regulatory documentation.

Inventory Standardization and SKU Management

Suture inventories can become complex quickly because one product family may contain many combinations of material, diameter, length, needle type, needle size, and coating.

Adding antimicrobial-coated alternatives without a standardization process can increase SKU counts and create opportunities for picking or stocking errors.

A structured inventory review can identify:

  • High-use configurations
  • Low-use configurations
  • Specialty products
  • Duplicate or near-duplicate items
  • Antimicrobial and non-antimicrobial variants
  • Clinically approved substitutes
  • Products restricted to specific service lines

Clinical leaders should determine which configurations are needed. Procurement teams can then support a standardized catalog that preserves those clinical requirements while improving item identification and ordering consistency.

Forecasting Procedure-Based Demand

Historical suture consumption is useful. Procedure volume can provide additional context.

Practices can review expected demand by:

  • Surgical specialty and procedure type
  • Operating room
  • Closure technique
  • Clinician or service line
  • Suture material
  • Size and needle combination
  • Seasonal procedure patterns

For a facility adopting triclosan-coated sutures following the SIS abdominal-surgery recommendation, forecasting may need to distinguish abdominal incision closure inventory from sutures used elsewhere.

This prevents a procedure-specific clinical decision from unintentionally becoming a facility-wide substitution.

Storage, Handling, and Traceability

Storage and Handling

Storage requirements differ by product. Follow the individual manufacturer’s labeling and IFU rather than relying on a universal storage rule.

Inventory procedures should generally support:

  • Required environmental conditions
  • Package integrity
  • Sterility maintenance
  • Expiration-date monitoring
  • Lot or batch traceability
  • First-expiring inventory rotation where appropriate
  • Separation of different sizes and configurations
  • Clear identification of coated and uncoated products

Any product with damaged sterile packaging, compromised integrity, or conditions inconsistent with its labeling should be handled according to applicable manufacturer instructions and facility procedures.

Traceability From Procurement to Point of Use

Traceability is particularly important for implanted medical devices and sterile surgical supplies.

Procurement records should allow your organization to determine:

  • What product was purchased
  • From whom it was sourced
  • Which lot or identifying information was received
  • Where the inventory entered the healthcare system

Pipeline Medical’s verified procurement platform provides authorized sourcing for licensed medical professionals. All products undergo manufacturer verification, batch traceability, and FDA-compliant handling from warehouse to clinic.

For applicable products, organizations may also incorporate UDI information, manufacturer catalog numbers, lot information, and expiration dates into inventory controls.

Traceability supports inventory management, product verification, recall response, and postmarket safety processes. It does not replace clinical documentation requirements applicable to the procedure.

Supplier Verification and Product Authenticity

Sterile surgical products should be obtained through a supply pathway that allows your healthcare organization to verify product identity and source.

When reviewing a procurement source, practices can examine:

  • Product identification
  • Manufacturer information
  • Catalog or reference number
  • Lot information where applicable
  • Expiration information
  • Sterile-package condition
  • Chain of custody
  • Delivery and handling controls
  • Documentation supporting product traceability

These controls are particularly important when several similar configurations exist within the same suture family.

A procurement description should provide enough specificity to distinguish the exact item required by the clinical team.

Integrating Guideline Recommendations Into Policy

Clinical evidence and procurement policy serve different functions.

A clinical guideline may establish that an intervention is appropriate or worth considering in a particular setting. Procurement then translates the approved clinical decision into reliable product availability.

A useful governance process:

  1. Clinical review: Surgical and infection-prevention leaders review current guidelines and evidence.
  2. Product review: Identify products whose labeling and characteristics match the intended clinical application.
  3. Formulary decision: Determine which configurations are approved for use.
  4. Procurement setup: Establish exact item numbers, sourcing pathways, and reorder parameters.
  5. Inventory controls: Implement storage, lot traceability, expiration monitoring, and stock organization.
  6. Periodic reassessment: Review clinical guidance, product labeling, utilization, availability, and institutional SSI data as appropriate.

This keeps product-selection decisions with qualified healthcare professionals while allowing procurement teams to execute that decision consistently.

Antibacterial Sutures Within Your Broader SSI Strategy

No suture technology should replace established SSI-prevention practices.

SHEA/IDSA/APIC specifically places antiseptic-impregnated sutures in its Additional Approaches category rather than among Essential Practices.

The CDC likewise addresses triclosan-coated sutures within a much broader SSI-prevention guideline rather than treating the product as an independent prevention system.

This means antimicrobial-coated sutures should be considered within the full surgical pathway.

Individual outcomes vary. An antimicrobial-coated suture cannot guarantee that an SSI will not occur.

Ready to Standardize Your Suture Inventory?

Suture procurement sits at the intersection of clinical evidence, device selection, infection prevention, and supply-chain management. Current guidelines provide meaningful support for triclosan-coated sutures—but with different scopes and levels of strength.

The 2025 SIS guideline offers the strongest, most procedure-specific recommendation, supporting triclosan-coated sutures for incision closure following abdominal operations in adults. SHEA/IDSA/APIC places antiseptic-impregnated sutures among Additional Approaches. CDC recommends considering triclosan-coated sutures, and WHO provides a conditional recommendation.

These should not be converted into a blanket claim for all antibacterial sutures or all surgical procedures.

Healthcare organizations should start with the clinical requirements of the closure, identify the exact suture material and configuration required, review current product labeling and IFU, and then determine whether an antimicrobial-coated option fits your clinical protocol.

Connect with Pipeline Medical’s procurement team to standardize your suture inventory, confirm exact product configurations, and develop a sourcing plan that supports your clinical protocols. Our team works with licensed surgical centers to verify product specifications, maintain traceability controls, and ensure reliable supply of the exact items your clinical team has approved.


The information provided on this site is for informational purposes only and is not intended to substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider or medical professional for guidance on any medical concerns, product use, or treatment decisions.

Frequently Asked Questions

What is an antibacterial suture?

“Antibacterial suture” is a broad description for a surgical suture incorporating an antimicrobial technology intended to inhibit certain microorganisms under conditions specified by the product’s labeling. Guidelines may instead use terms such as triclosan-coated suture, antimicrobial-coated suture, or antiseptic-impregnated suture. These terms should not automatically be treated as interchangeable. The specific coating, underlying suture, labeling, and evidence base should be reviewed for each product.

Do current guidelines recommend triclosan-coated sutures?

Yes, but scope and strength differ by guideline:

  • 2025 SIS: Grade 1A recommendation for incision closure after abdominal operations in adults
  • 2022 SHEA/IDSA/APIC: Additional Approach, moderate-quality evidence
  • CDC 2017: Category II recommendation to consider for SSI prevention
  • WHO: Conditional recommendation based on moderate-quality evidence (evidence review involved triclosan-coated absorbable sutures)

Does the SIS recommendation apply to every surgery?

No. The 2025 SIS clinical question and recommendation specifically address adult patients undergoing abdominal surgery for incision closure. Using that recommendation to claim universal support for all operations extends beyond its defined scope.

Are antibacterial sutures a replacement for other SSI-prevention measures?

No. Current guidelines position antimicrobial-coated or antiseptic-impregnated sutures as one element of a broader SSI-prevention strategy. SHEA/IDSA/APIC categorizes them as Additional Approaches rather than Essential Practices.

Are all antimicrobial-coated sutures supported by the same evidence?

No. The major recommendations are most directly connected to triclosan-coated sutures. WHO explicitly notes that its reviewed evidence evaluated triclosan-coated absorbable sutures and did not identify comparable studies of other antimicrobial agents in that review. A different coating or antimicrobial technology should be evaluated using its own regulatory documentation, labeling, IFU, and applicable evidence.

Are surgical sutures FDA approved?

Regulatory terminology should be product-specific. Many common surgical suture categories are Class II medical devices using the FDA 510(k) pathway. In those cases, FDA-cleared may be the appropriate terminology rather than FDA-approved. Healthcare organizations should verify the status of the exact product.

What should procurement teams compare when selecting a suture configuration?

After the clinical team establishes the appropriate product requirements, procurement teams may compare material, absorbability, filament structure, USP size, length, needle configuration, strength-retention or absorption characteristics, antimicrobial coating where applicable, packaging, exact catalog number, availability, and manufacturer documentation. Clinical equivalence should not be inferred solely from similar product descriptions.

Should a coated suture automatically replace an uncoated version?

No. Any substitution should account for clinical requirements, product labeling, applicable guidelines, the exact suture and needle configuration, and the healthcare organization’s approved product-selection process. An antimicrobial coating does not by itself establish interchangeability.

How should practices track antibacterial suture inventory?

Use product-specific identifiers sufficient to distinguish material, size, length, needle configuration, coating status, and other clinically relevant differences. Lot information, expiration dates, manufacturer information, UDI data where applicable, and receiving records can further support traceability and recall readiness.

Where should clinicians report a suspected device problem?

Healthcare professionals, patients, and consumers may voluntarily report medical-device adverse events through FDA’s MedWatch program using FDA Form 3500. Separate mandatory medical-device reporting requirements may apply to manufacturers, importers, and certain device user facilities.

Key Takeaways

  • The 2025 SIS guideline recommends triclosan-coated sutures for incision closure after abdominal operations in adults (Grade 1A)
  • SIS recommendation is procedure-specific and should not be generalized to every surgical procedure
  • 2022 SHEA/IDSA/APIC update classifies antiseptic-impregnated sutures as an Additional Approach to SSI prevention
  • CDC 2017 recommends considering triclosan-coated sutures (Category II)
  • WHO provides a conditional recommendation for triclosan-coated sutures, but evidence involved triclosan-coated absorbable sutures specifically
  • Antimicrobial coatings are one product characteristic. Suture material, absorbability, construction, size, needle configuration, tissue requirements, and labeling remain important selection factors
  • Many surgical suture types are FDA Class II devices, making product-specific regulatory terminology important
  • Antibacterial sutures should be part of a broader SSI strategy, not a replacement for established prevention practices
  • Procurement controls should support exact product identification, authorized sourcing, storage, lot traceability, expiration monitoring, and recall readiness
  • Clinical product-selection decisions remain with qualified healthcare professionals

Conclusion

Antibacterial suture procurement requires balancing clinical evidence, device selection, infection prevention, and supply-chain management.

Current guidelines provide meaningful support for triclosan-coated sutures, but with different scopes and recommendation strengths. The 2025 SIS guideline provides the strongest and most procedure-specific current recommendation, supporting triclosan-coated sutures for incision closure following abdominal operations in adults. SHEA/IDSA/APIC places antiseptic-impregnated sutures among Additional Approaches, while CDC recommends considering triclosan-coated sutures and WHO provides a conditional recommendation.

These recommendations should not be converted into a blanket claim for all antibacterial sutures or all surgical procedures.

Healthcare organizations should begin with the clinical requirements of the closure, identify the exact suture material and configuration required, review current product labeling and IFU, and then determine whether an antimicrobial-coated option fits your clinical protocol.

Procurement teams can support that decision through exact-item identification, authorized sourcing, inventory standardization, product traceability, storage controls, and reliable supply planning. This approach keeps clinical decisions in the hands of qualified healthcare professionals while helping ensure that selected surgical products move through a controlled and documented procurement pathway.

Important Safety Note

Surgical sutures are medical devices intended for use by qualified healthcare professionals. Selection and use should be based on the specific product’s labeling and Instructions for Use, the tissue and procedure involved, appropriate surgical technique, applicable clinical guidance, and patient-specific considerations.

Warnings, contraindications, precautions, absorption characteristics, tensile-strength profiles, tissue reactions, and other safety information differ among suture materials and products. FDA guidance specifically identifies these elements as essential to surgical-suture labeling. Healthcare professionals should review the complete current labeling and IFU for the exact product before use.

Use of an antimicrobial-coated suture does not eliminate SSI risk. Individual clinical outcomes vary. Guideline recommendations describe evidence across studied populations rather than guaranteed results for an individual patient.

Healthcare professionals may voluntarily report suspected medical-device adverse events, product-quality problems, or other device problems through FDA MedWatch using the applicable reporting pathway. FDA also maintains separate Medical Device Reporting requirements for entities subject to mandatory reporting.

This article provides general professional education and procurement information. It does not constitute medical advice, prescribe a particular device, establish product interchangeability, or replace the product’s labeling and IFU, current clinical guidelines, institutional policy, or the judgment of qualified healthcare professionals.

References

  1. Forrester JD, Seshadri A, Patel N, et al. Surgical Infection Society Guidelines for Use of Antimicrobial Agent-Coated Suture to Reduce the Risk of Surgical Site Infection after Abdominal Operation. Surgical Infections. 2025;26(6):441–450. DOI: 10.1089/sur.2025.011.
  2. Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to Prevent Surgical Site Infections in Acute-Care Hospitals: 2022 Update. Infection Control & Hospital Epidemiology. 2023;44(5):695–720.
  3. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surgery. 2017;152(8):784–791.
  4. World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. Section 4.22: Antimicrobial-Coated Sutures.
  5. U.S. Food and Drug Administration. Surgical Sutures—Class II Special Controls Guidance Document for Industry and FDA Staff.
  6. U.S. Food and Drug Administration. Medical Device Reporting: How to Report Medical Device Problems.

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